A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00004583

Collaborator

(none)

660

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine	Phase 3

Detailed Description

Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.

Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

Study Start Date :

Mar 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this trial if you:

Are HIV positive.
Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
Are age 12 or older.
Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this trial if you:

Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
Are seriously ill or have an AIDS-related infection.
Are pregnant or breast-feeding.
Are taking certain medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Oaks Med Group	Beverly Hills	California	United States	90211
2	Orange County Ctr for Special Immunology	Fountain Valley	California	United States	92708
3	AIDS Healthcare Foundation	Los Angeles	California	United States	900276069
4	Tower ID Med Associates	Los Angeles	California	United States	90048
5	UCLA CARE Ctr	Los Angeles	California	United States	90095
6	San Francisco Veterans Administration Med Ctr	San Francisco	California	United States	94121
7	Harbor - UCLA Med Ctr	Torrance	California	United States	90502
8	Yale Univ / AIDS Clinical Trials Unit	New Haven	Connecticut	United States	06510
9	Steinhart Medical Associates	Miami	Florida	United States	33133
10	Univ of Miami School of Medicine	Miami	Florida	United States	33136
11	Infectious Disease Research Institute	Tampa	Florida	United States	33614
12	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
13	Emory Univ	Atlanta	Georgia	United States	30308
14	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
15	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
16	Univ of Kansas School of Medicine	Wichita	Kansas	United States	67214
17	Tulane Univ Med School	New Orleans	Louisiana	United States	70112
18	Johns Hopkins Hosp	Baltimore	Maryland	United States	21205
19	Boston Med Ctr	Boston	Massachusetts	United States	02118
20	Community Research Initiative of New England	Brookline	Massachusetts	United States	02445
21	Univ of Michigan Hospitals and Health Ctrs	Ann Arbor	Michigan	United States	481090378
22	Abbott Northwestern Hosp	Minneapolis	Minnesota	United States	55407
23	East Orange Veterans Administration Med Ctr	East Orange	New Jersey	United States	07018
24	Beth Israel Med Ctr	New York	New York	United States	10003
25	Cornell Clinical Trials Unit - Chelsea Clinic	New York	New York	United States	10011
26	Howard Grossman	New York	New York	United States	10011
27	SUNY at Stony Brook / Div of Infectious Disease	Stony Brook	New York	United States	117948153
28	Duke Univ Med Ctr / Infectious Disease Clinic	Durham	North Carolina	United States	27710
29	Holmes Hosp / Univ of Cincinnati Med Ctr	Cincinnati	Ohio	United States	452670405
30	Associates in Med and Mental Health	Tulsa	Oklahoma	United States	74114
31	Oregon Health Sciences Univ	Portland	Oregon	United States	972109951
32	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
33	Stephen Hauptman	Philadelphia	Pennsylvania	United States	19107
34	The Miriam Hosp	Providence	Rhode Island	United States	02906
35	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37203
36	Central Texas Med Foundation	Austin	Texas	United States	78751
37	Oaklawn Physicians Group	Dallas	Texas	United States	75219
38	Univ of Texas Southwestern Med Ctr	Dallas	Texas	United States	75235
39	Joseph C Gathe	Houston	Texas	United States	77004
40	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
41	Univ of Virginia Health Sciences Ctr	Charlottesville	Virginia	United States	22908
42	Univ of Wisconsin	Madison	Wisconsin	United States	53792
43	Royal Brisbane Hosp	Herston		Australia
44	Royal Perth Hosp	Perth		Australia
45	Alfred Hosp	Prahan		Australia
46	Pulmologisches Zentrum Der Stadt Wien	Wien		Austria
47	Hosp Evandro Chagas Fioernz	Manguinhos RJ		Brazil
48	Castelo	Sao Paulo		Brazil
49	Fundacao Zerbini Casa Da Aids	Sao Paulo		Brazil
50	Hosp Do Servidor Publico Estadual De Sao Paulo	Sao Paulo		Brazil
51	Hosp Heliopolis	Sao Paulo		Brazil
52	Saint Paul's Hosp	Vancouver	British Columbia	Canada
53	Ottawa General Hospital	Ottawa	Ontario	Canada
54	Toronto Gen Hosp	Toronto	Ontario	Canada
55	Clinique Medicale du Quartier Latin	Montreal	Quebec	Canada
56	Clinique Medicale L'Actuele	Montreal	Quebec	Canada
57	Montreal Chest Institute	Montreal	Quebec	Canada
58	Righospitalet	Copenhagen		Denmark
59	Hvidovre Univ Hosp	Hvidovre		Denmark
60	Centre Hospitalier De Compiegne	Compiegne		France
61	Groupe Hospitalier Bichat-Claude Bernard	Paris Cedex 18		France
62	CHU De Bicetre	Paris		France
63	Hopital Paul Brousse	Villejuif		France
64	EPIMED	Berlin		Germany
65	Heinrich Heine Universitat	Dusseldorf		Germany
66	Klinikum Der Johann Wolfgang Goethe Universitat	Frankfurt		Germany
67	Allgemeines Krankenhaus St Georg	Hamburg		Germany
68	Univ Zu Koeln	Koeln		Germany
69	Ctr of AIDS Diagnosis and Treatment	Warszawa		Poland
70	Clinical Research Puerto Rico Inc	San Juan		Puerto Rico	00909
71	Miller	Belford Gardens		South Africa
72	Cyrildene	Johannesburg		South Africa
73	Wits Medical School	Parktown		South Africa
74	Hosp Germans Trias I Pujol	Barcelona		Spain
75	Hosp Carlos III	Madrid		Spain
76	Hosp De Mostoles	Madrid		Spain
77	Hosp Doce De Octubre	Madrid		Spain
78	Hosp La Paz	Madrid		Spain
79	Hosp Virgen Del Rocio	Sevilla		Spain
80	Universitatsspital Zurich	Zurich		Switzerland
81	Brighton Gen Hosp	Brighton		United Kingdom
82	Imperial College School of Medicine	London		United Kingdom
83	Royal Free Hosp	London		United Kingdom